Match score not available

Clinical Data Manager

Remote:

Full Remote

Contract:

Full time

Experience:

Mid-level (2-5 years)

Work from:

Germany

Offer summary

Qualifications:

BS/BA in scientific discipline; MS preferred, 3 years related experience required, Expert knowledge of eClinical processes, Experience with global studies and CROs, Proficiency with MS Office Suite.

Key responsabilities:

Develop and implement data management systems
Lead cross-functional reviews and database activities
Monitor data collection and vendor performance
Collaborate with internal and external partners
Review clinical protocols and manage timelines

RQM+ SME https://www.rqmplus.com/

501 - 1000 Employees

See more RQM+ offers

Job description

Your missions

The Clinical Data Manager develops and implements data-oriented systems to meet the needs of the organization. Duties include developing systems, procedures, and policies for data management for the Clinical Trials team and assisting colleagues in performing data-related tasks.

Primary Responsibilities

Contributes to data management activities including eCRF development by leading cross-functional reviews of eCRF content.

Establishes Database building activities, including review of edit check specifications and performance of user acceptance testing.

Monitors data collection, remote and source data verification (SDV), coding, and cleaning by vendors through tracking of study metrics and targeted data reviews

Oversees of database lock activities and ultimate archiving of study data

Collaborates with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Medical, Quality Assurance, Product Safety; CROs, central and local laboratories, and other vendors.

Establishes cross-functional, internal data review plans, coordinate data cuts/transfers, and conduct data reviews.

Reviews CRO data management plans, CRF completion guidelines, edit check specifications, external data transfer specifications and other study documentation.

Represents data management and effectively communicate requirements, strategy, timelines and deliverables at internal cross-functional team meetings and meetings with external vendors.

Participates in the drafting and/or review of timelines consistent with company goals and ensure all deliverables and milestones are met.

Reviews clinical protocols/amendments, clinical study reports, statistical analysis plans, etc.

Supports GCP inspection readiness

Requirements

BS/BA in scientific discipline, MS or equivalent preferred, with at least 3 years related experience in a medical device/diagnostic/software/pharmaceuticals/biologics/biotechnology company

Experience with global studies, utilizing an outsourced CRO model.

Experience in clinical MedTech and drug development through concept to post-approval

Education or work experience in a health-related field

Expert knowledge of eClinical processes, efficient design/build of an EDC data management system and other Clinical Trial/Data Management Systems

Knowledge and understanding of regulations and industry-adopted data standards, such as CDISC SDTM and CDASH

Experience working with multiple EDC platforms.

Experience using standardized medical terminology, including MedDRA and WHODrug

Experience working with MS Office Suite (Excel, Word, and PowerPoint) and familiarity with MS Project

Excellent written and oral communication skills

Highly motivated and flexible, with excellent organizational and time management skills

Ability to work independently and as part of a multi-disciplinary team

Understanding of ICH GCP as well as general knowledge of industry practices and standards

Knowledge and understanding of regulatory requirements and expectations for clinical data systems including 21 CFR Part 11 and applicable ISO and CFR regulations.

Behaviors

Action-Oriented, Approachability, Building Effective Teams, Business Acumen, Career Ambition, Composure, Courage (Managerial), Customer Focus, Decision Quality, Informing, Integrity & Trust, Interpersonal Savvy, Planning

Being an industry leader in regulatory and quality consulting is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today!

We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.